BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 4903502 · Received July 9, 2015

    Report

    Report Number
    2647580-2015-00494
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 8, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE NUMBER: (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE ENDO GIA¿ ULTRA UNIVERSAL 12MM SINGLE USE INSTRUMENT AND ONE ENDO GIA 60MM ARTICULATING EXTRA THICK RELOAD OPENED BY THE ACCOUNT. INITIAL VISUAL INSPECTION OF THE INSTRUMENT NOTED THAT IT WAS ENGAGED WITH THE RELOAD AND THE RETURN KNOBS WERE ADVANCED. VISUAL EVALUATION OF THE RELOAD NOTED THAT IT WAS FULLY FIRED WITH ITS JAWS CLAMPED. THE ANVIL CLAMPING MECHANISM WAS DEFORMED. TISSUE CONTAINING SEVERAL MALFORMED STAPLES WAS OBSERVED IN THE RELOAD JAWS. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. SUB-FLUSH STAPLE PUSHERS RELATIVE TO THE STAPLE CARTRIDGE WERE OBSERVED AND VISUALIZATION OF INTERNAL COMPONENTS NOTED THAT THE SLED VANE TIPS WERE DEFORMED. FURTHER ENGINEERING EVALUATION OF THE LOCKED ON TISSUE CONDITION ALSO NOTED AN OUT OF POSITION KNIFE BAR LAMINATE WITHIN THE RELOAD. THIS VARIATION DOES NOT INTERFERE WITH NORMAL FUNCTION WHEN APPLIED ACCORDING TO THE INSTRUCTIONS FOR USE. THE FIRING KNOBS WERE FULLY RETRACTED AND THE RELOAD JAWS OPENED. THE RELOAD WAS UNLOADED FROM THE INSTRUMENT. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH POST MARKET VIGILANCE (PMV) REPRESENTATIVE STRAIGHT AND ROTICULATOR¿ LOADING UNITS. DURING THE FIRING CYCLE, SEVERAL SKIPS WERE AUDIBLE IN THE FIRING STROKE. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS. THIS EXAMINATION NOTED SHEARED TEETH ON THE FIRING RACK. THE RELOAD WAS LOADED INTO A PMV INSTRUMENT FOR FUNCTIONAL EVALUATION. THE RELOAD ANVIL COULD NOT BE CLOSED COMPLETELY ON THE INITIAL CLAMPING STROKE AS A RESULT OF THE DEFORMED ANVIL CLAMPING MECHANISM. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TYPE OF PROCEDURE: VATS ACCORDING TO THE REPORTER: CUSTOMER REPORTS THAT THE STAPLER WOULD NOT OPEN ONCE FIRED. A SECOND STAPLER WAS OPENED. THIS FIRING WAS UTILIZED TO SEPARATE THE FIRST STAPLER FROM THE PATIENT'S LUNG TISSUE. A SCALPEL WAS THEN USED TO REMOVE THE SPECIMEN LUNG TISSUE FROM THE FIRST STAPLER. WE THEN COVERED THE STAPLER, WHICH STILL CONTAINED TISSUE WITHIN IT, WITH AN OPSITE IN ORDER TO REMOVE IT VIA THE VATS PORT. THE PATIENT REQUIRED CONVERSION FROM A VATS APPROACH TO A THORACOTOMY IN ORDER TO REMOVE THE STAPLER. THERE WAS NO REINFORCEMENT MATERIAL USED. THERE WAS UNANTICIPATED TISSUE LOSS AND THE TISSUE TORN. THERE WAS BLOOD LOSS OVER 500CCS BUT A BLOOD TRANSFUSION WAS NOT REQUIRED. SURGICAL TIME WAS DELAYED BY MORE THAN 30 MINUTES. PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445964 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention